System Analyst

Key Responsibilities

• Prepare and execute Computer System Validation (CSV) deliverables, including SLIA, DIRA, DSA, PURS, SRA, FS, DS, and SOPs.
• Prepare and execute FAT, SAT, IQ/OQ, H/SIOQ and SIOQ protocols, and associated Summary Reports.
• Lead system commissioning, Factory Acceptance Tests (FAT), and Site Acceptance Tests (SAT).
• Coordinate with cross-functional manufacturing and process teams to gather system requirements and manage project documentation.
• Manage Project Change Management (PCM) documentation and processes.
• Support OT system impact assessments across System Level, Component Level, Data Integrity, and Data Security.
• Configure and maintain communication between PLCs and DCS platforms (e.g. Profinet, Modbus, CAN Bus).
• Support 21 CFR Part 11 e-records/e-signature compliance, including alarm, audit, and batch reporting.
• Work across multi-platform automation systems including Siemens, Schneider, and Allen Bradley, with DeltaV DCS integration.
• Support validation and control of GMP-critical systems such as CIP/SIP, autoclaves, WFI, HVAC, and BMS/EMS.

Requirements

• Diploma/Degree in Automation, Electrical, Instrumentation, or a related Engineering discipline.
• At least 5-9 years of relevant experience in automation and computer system validation within GMP-regulated pharmaceutical or biotech environments.
• Strong working knowledge of GAMP 5 and 21 CFR Part 11 requirements.
• Hands-on experience with PLC/SCADA platforms such as Siemens (S7-1200/1500, TIA Portal, WinCC), Schneider EcoStruxure, and/or Allen Bradley.
• Familiarity with DeltaV DCS integration is an advantage.
• Experience with electronic validation platforms (e.g. Kneat) is an advantage.
• Understanding of ISA-88 (S88) batch control systems is a plus.
• Good communication and cross-functional coordination skills able to work independently and lead documentation efforts.